MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LIGHTTRAIL? SINGLE USE; POWERED LASER SURGICAL INSTRUMENT

Model Number	M0068F64500
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation, the fiber exploded with a spark after confirming the settings to ready.The procedure was completed with another device.There were no patient complications reported.
Event or Problem Description
It was reported that during preparation, the fiber exploded with a spark after confirming the settings to ready.The procedure was completed with another device.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the fiber was thoroughly analyzed.Visual inspection confirmed that the fiber was received in two pieces, a fiber body break was observed.Microscopic inspection found the fiber tip was good and the connector with no defects.Functional inspection was performed and the console read; fiber may not be used anymore.Please connect new fiber.Code 1101.The labeling review was performed and found that the product instructions for use (ifu) states, carefully inspect the fiber for kinks, punctures, fractures or other damage.If the fiber appears damaged, do not use the device.Return it to boston scientific for replacement.A device history record (dhr) review indicates the device met all manufacturing specifications, and therefore the failure was unlikely related to manufacturing.

• Brand Name: LIGHTTRAIL? SINGLE USE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21589388
• Report Number: 2124215-2025-15225
• Device Sequence Number: 8925652
• Product Code: GEX
• UDI-Device Identifier: 08714729939764
• UDI-Public: (01)08714729939764(17)251130(10)33481374
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: M0068F64500
• Device Catalogue Number: M0068F64500
• Device Lot Number: 0033481374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown